METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND FENOFIBRATE BY RP-HPLC METHOD IN MARKETED FORMULATION

A new precise, accurate, reliable validated method has been developed by using reverse phase high performance liquid chromatography (RP-HPLC) for the determination of Metformin and Fenofibrate in pharmaceutical dosage form. Chromatographic separation was carried out using mobile phase buffer (0.02M Potassium dihydrogen phosphate): Acetonitrile: Methanol (40:50:10, PH-5.65 adjusted with Orthophosphoric acid) on Hypersil Silica column (250 x 4.6 mm, 5) at a flow rate 1.0ml/min at 30°C. Photodiode array is used as detector and Detection was carried out at 225nm wavelength.The retention times for Metformin and Fenofibrate were 7.436 min and 2.999 min respectively. Both the drugs showed good linearity in the range of 250-750 µg/ml for metformin and 80-240 µg/ml for Fenofibrate. The proposed method has been successfully applied to pharmaceutical formulation and was validated according to ICH guidelines. Method showed good precision with %RSD less than 2%. The percentage recovery for Metformin and Fenofibrate was found between 99.39-100.61% and 100.47-101.43% respectively. And it indicates that the proposed method was accurate and precise.